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2Nd Shift Printing Coach
Company | Viant Medical |
Address | South Plainfield, NJ, United States |
Employment type | PART_TIME |
Salary | |
Category | Medical Equipment Manufacturing |
Expires | 2023-06-16 |
Posted at | 11 months ago |
General Description
- Follow and ensure that all personnel comply with FDA regulations, ISO standards, customer requirements, and SOPs as defined by Viant’s policies and procedures.
- Maintaining personal hygiene
- Communicate with previous shift to determine any quality or production concerns or issues
- Immediately report any unsafe work conditions or accidents to the Supervisor
- Notify Assistant Supervisor or Supervisor of any quality defects immediately when identified
- Follow appropriate gowning procedures and specifications as outlined in ENVIRONMENTAL CONTROL – MAINTENANCE OF CLEANROOMS AND GOWNING PRACTICES (VQMS Document NJ-QS-00132) and Gowning and De-Gowning Procedure (VQMS Document NJ-QS-00687)
- Follow 5S and keep the work areas neat and clean to maintain a safe working environment
- Notify Supervisor of excess scrap and rejectable product. Keep workstation clean, neat and orderly at all times.
- All other safety or personal protective equipment guidelines not outlined in the job description, but outlined by workmanship standards, job SOPs, or OSHA must be followed
- At the beginning of each shift, operators will pull one shot and reprint the last label for each assigned machine. The label will be affixed to a bag containing the shot and put in bins outside of the Quality Lab
- Keep workstation clean, neat, and orderly at all times during shift.
- Safety Glasses must be worn at all times when on the Production Floor
- Pack, weigh, and label product per workmanship standard
- All parts should be in appropriate packaging as designated by Work Instructions. Employees are responsible to remove/clean up/ sweep up any stray pieces that are on the ground neat workstation and assigned machine(s) throughout shift.
- If parts are found to be rejectable, Operator will notify Supervisor. Comply with dress code requirements at all times.
- Move full bins into aisle to be removed and replace with empty bin.
- Ensure that workstation and machine(s) are clean and any applicable tools or parts required are refilled for next shift.
- Operators will keep scrap count and enter scrap information in IQMS every 2 hours
- Reporting illness to their supervisor before entering the cleanroom, under the discretion of the supervisor or assistant supervisor, work in the cleanroom may be restricted
- Notify Assistant Supervisor and/or Supervisor if machine is producing scrap or reject-able parts
- At the start of shift, verify that workmanship standards for the job running on the machine is posted and that you are fully trained to and understand the workmanship standards
- No headphones or any other device that could distract from activities and create an unsafe environment
- Other responsibilities as assigned
- Follow cleanroom requirements as outlined in ENVIRONMENTAL CONTROL – MAINTENANCE OF CLEANROOMS AND GOWNING PRACTICES (VQMS Document NJ-QS-00132) including but not limited to:
- Refraining from touching unnecessary objects after washing hands or donning gloves
- At beginning of shift receive machine assignment from Assistant Supervisor and/or Supervisor
- The usage of cellphones or electronic devices are prohibited when on the Production Floor
- Sanitizing hands after touching exposed skin
- Follow instruction by Assistant Supervisor and/ or Supervisor relative to rotation breaks, work assignment, and relief of other machine
- Inspect work site at start of shift. Compare route sheet or specifications to labels to insure conformance to requirements. Inspect product dimensionally and visually as required by Q.C. documentation.
- Segregating product and reporting the incident to the supervisor or assistant supervisor if product has been potentially contaminated by a cough or sneeze
- At the beginning of each shift, Operators shall inspect workstation and clean by wiping tables, bins, chair(s), shelves, and fixtures with Alcohol and record data in cleaning log.
- Follow appropriate dress code and personal hygiene requirements outlined in ENVIRONMENTAL CONTROL – MAINTENANCE OF CLEANROOMS AND GOWNING PRACTICES (VQMS Document NJ-QS-00132) and cGMP: Current Good Manufacturing Practices (VQMS Document VM-Temp-0052) including but not limited to:
- Follow instruction by Supervisor relative to rotation, breaks, work assignment, and relief of other machines.
- Operators must log in to IQMS at the beginning of each shift and log out of IQMS at the end of each shift
- Communicate with previous shift to determine any quality or production concerns. Mattec system: Enter operator number, keep scrap count and enter scrap information
- Removing coats, winter boots, and other outdoor garments at the coat or gowning room
- No gum, food, or beverages
- Pack, weigh, and label product per route sheet or specification requirements.
- Employees MUST wash hands prior to entering the Clean Room
- Follow all personal protective equipment procedures and specifications
- Comply with all safety requirement and specifications to ensure a safe and healthy work environment including, but not limited to:
- Inspect parts/ products that are being produced to ensure that they meet the customer’s specifications and Quality requirements as outlined in the Standard Work Instructions
- Able to work in a team environment
- Able to work assigned shift and schedule
- Good communication skills
- Able to read, understand, and follow written procedures and specification worksheets
- Able to learn and retain the steps required to produce an acceptable molded part
- Able to understand and follow verbal and written instructions in English
- Ability to use measuring devices and hand tools
- Organized and able to manage priorities
- Reliable and able to work assigned shift and schedule
- Able to take responsibility for accuracy of work
- High School Diploma or GED
- Frequently required to lift, move, push up to 35 lbs
- Noise; Sufficient noise to cause a worker to shout in order to be heard above ambient noise level
- Hazards; which include a variety of physical conditions such as: proximity to moving mechanical parts, moving vehicles, electrical current, working on scaffolding and high places, exposure to high heat or exposure to chemicals
- Vibration; Exposure to oscillating movements of the extremities or whole body
- Inside environmental conditions; Protection from weather conditions but not necessarily from temperature change
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